Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation

NCT06478342 | Not Yet Recruiting

• 1 other identifier: PFA - strain
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Pulsed field ablation (PFA) has emerged in routine clinical practice as a new promising technology in catheter-based treatment of atrial fibrillation (AF). The ease of PFA technology enables more extensive ablation in shorter time. On one hand, extensive ablation is advocated to decrease the AF recurrence in persistent patients, on the other hand it is an important predictor of developing left atrial stiff syndrome with a reported incidence rate of 3.7 - 8.2 % in persistent patients during the era of radiofrequency ablation. Goals of the study: The main hypothesis is that the LA function (strain) will tend to decline after extensive PFA. It will be assessed using transthoracic echocardiography (TTE) and magnetic resonance (MRI). Secondary endpoint analysis will include the evaluation of the distribution of late gadolinium enhancement (LGE) after ablation compared to baseline scans, evaluation of heart failure biomarkers after ablation, and description of the rate of AF recurrence. Methods: This project is a prospective, nonrandomised, two-centre (University Hospital Kralovske Vinohrady and University Hospital Motol) observational study including 50 non-paroxysmal AF patients with indication for catheter ablation. Before the ablation, all patients will undergo LGE MRI and TTE (after cardioversion if AF present). The ablation procedure will be performed using pulsed field technology and will include pulmonary vein isolation, posterior wall ablation and mitral isthmus ablation. Patients will be followed for 6 months. 3 months after the ablation, LGE MRI will be performed. TTE examinations will be carried out on the day after the ablation, at 3 and at 6 months. Heart failure biomarkers (N-terminal proatrial natriuretic peptide, fibroblast growth factor 23, and galectin 3) levels will be analysed at baseline, and 3 and 6 months after the procedure. ECG Holter monitoring will be performed at 3- and 6-months visits.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pulsed field ablation; left atrial strain

Outcome Measures

Primary Outcomes (2)

• Changes in LA function (strain) by MRI (baseline vs. 3m values)

  LA strain (baseline vs. 3 months)

  Baseline MRI to 3 months after procedure

• Changes in LA function (strain) by TTE (baseline vs. 3m values)

  LA strain (baseline vs. 3 months)

  Procedure to 3 months

Secondary Outcomes (4)

• Changes in LA fibrosis distribution (LGE MRI) (baseline vs. 3 m values)

  Baseline MRI to 3 months after procedure

• Changes in ANP, FGF 23, GAL 3 levels (baseline vs. 3 m values)

  baseline vs. 3 m values

• AF freedom

  Procedure to 6 months visit

• Changes in strain function on TTE over time

  baseline TTE to 6 months control

Study Arms (1)

Prospective cohort

Non-paroxysmal AF patients

Procedure: ablation

Interventions

ablation PROCEDURE

Pulsed field ablation, MRI and TEE examinations (LA strain)

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for AF ablation procedures

You may qualify if:

• Non-paroxysmal AF with an indication for catheter ablation
• Age above 18
• Signed informed consent

You may not qualify if:

• Contraindication to MRI
• BMI \> 35 kg/m2
• Contraindication to amiodarone
• Left atrial size \> 60 mm
• History of any LA ablation
• Significant valvular disease (mitral regurgitation ¾ or greater, moderate or severe aortic stenosis)
• Severe pulmonary hypertension
• Pregnancy

Sponsors & Collaborators

• Charles University, Czech Republic: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marek Hozman, MD

CONTACT

+420267161111; marek.hozman@fnkv.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: electrophysiologist

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: June 27, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share